Kornimate/medical-research-clean huggingface dataset:
buccal film vs iv palonosetron for prevention of cinv in cancer patients receiving mec

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: the phase 3 study is to compare the efficacy and safety of palonosetron, a long-acting 5-ht3 receptor antagonist, by buccal film delivery compared to iv injection for the prevention of chemotherapy-induced nausea and vomiting. subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.

this is a phase 3 randomized, double-blind, parallel group study designed to evaluate the efficacy and safety of palonosetron hcl buccal film versus iv palonosetron for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy (mec). subjects are randomized into two treatment groups, one with the experimental study drug palonosetron in buccal film, the other one with the control treatment using palonosetron hydrochloride iv injection. palonosetron pk will be assessed in a subgroup of each treatment group (two sample points, 10% of subjects).

Eligibility criteria:
inclusion criteria: 1. male or female, at least 18-years of age; 2. provide written informed consent; 3. chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer; 4. karnofsky index ≥ 50; 5. be scheduled to receive mec to be administered on day 1; exclusion criteria: 1. unable to understand or cooperate with study procedure； 2. received any investigational drug 30 days prior to study entry； 3. used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study； 4. enrollment in a previous study with palonosetron； 5. seizure disorder requiring anticonvulsant medication; 6. experienced any vomiting, retching, or nci common toxicity criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy； 7. ongoing vomiting from any organic etiology； 8. experienced nausea (moderate to severe or vomiting following any previous chemotherapy)； 9. scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study； 10. known contraindication to 5-ht3 antagonist or dexamethasone； 11. scheduled to receive bone marrow or stem cell transplant during study; 12. symptomatic primary or metastatic cns malignancy; 13. lactating female.
efficacy of suvorexant in the treatment of hot flash-associated insomnia

Conditions: Insomnia

Summary: the aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.


Eligibility criteria:
inclusion criteria: * peri- or postmenopausal women * dsm-5 criteria for insomnia disorder, with onset of symptoms attributed to hot flashes * some awakenings co-occur with a hot flash * score on the insomnia severity index (isi) measure ≥15 * hot flashes present, including at night exclusion criteria: * diagnosis of other primary sleep disorders * shift workers * current or expected use of hypnotic medications * current major depressive episode * lifetime history of bipolar disorder, psychosis, or other serious mental health problem * current alcohol/substance use disorder * obesity * renal or hepatic disease * pregnancy or breastfeeding * recent malignancy * recent surgery * neurological disorder or cardiovascular disease raising safety concerns * medical instability considered to interfere with study procedures * concomitant medications with drug interaction or co-administration concerns * contraindications or allergic responses to suvorexant * recent or planned travel across time zones * excessive coffee or cigarette use

Keywords: insomnia hot flashes menopause suvorexant belsomra
multicenter comparison of early and late vascular responses to everolimus-eluting cobalt-chromium stent

Conditions: Coronary Artery Disease

Summary: to treat patients with stable coronary artery disease, elective percutaneous coronary intervention (pci) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: ees, xience prime, xpedition), which is the current standard drug-eluting stent (des). vascular responses at the site of stent placement will be evaluated by optical coherence tomography (oct) at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. the relationships between oct findings and the time course of platelet aggregation and between oct findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.


Eligibility criteria:
inclusion criteria: * patients having at least one de novo lesion in a coronary artery in whom pci with a des is indicated * patients aged 20 to less than 85 years at the time of informed consent * patients who have provided informed consent written by themselves * patients who are able to undergo oct examinations of the site of stent placement at 1 or 3 months and at 12 months exclusion criteria: * if it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.) * patients with acute myocardial infarction (ami) * patients in a state of shock * patients with cardiac failure * patients having a culprit lesion in the left main coronary artery trunk * patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate * patients having an in-stent restenosis lesion as the culprit lesion * patients having chronic renal failure with a serum creatinine level of 2.0 mg/dl or higher at a screening visit * patients on hemodialysis * cancer patients with a life expectancy of less than 2 years * patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months * pregnant women or women expected to become pregnant * patients with a history of adverse reactions to aspirin or clopidogrel (however, it is acceptable to enroll patients in whom the safety of ticlopidine has been confirmed, even if they have a history of adverse reactions to clopidogrel)
effects of lumbopelvic manipulation on neuromuscular activity of back & hip muscles in adults with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the purposes of this study are: 1. to examine the within-day and between-day test-retest reliability of a testing protocol measuring the back and hip muscles fatigability using emg median frequency 2. to examine the immediate and the carry-over effects of the lumbopelvic manipulation on the emg median frequency of the lumbar multifidus (mult), gluteus medius (gmed) and gluteus maximus (gmax) muscles in patients with chronic low back pain (clbp) 3. to compare the fatigability levels of the mult, gmed and gmax muscles by measuring the emg median frequency between the participants who will receive lumbopelvic manipulation. the research hypotheses are: 1. the testing protocol using emg median frequency as a fatigue indicator for mult,gmed and gmax muscles will have good (icc ≥ 0.80) within-day and between-day test-retest reliability. 2. the fatigability level of the mult, gmed and gmax muscles will significantly decrease immediately after the lumbopelvic manipulation and will be maintained over two to four days following the manipulation. 3. the fatigability of the mult, gmed and gmax muscles will significantly decrease after the intervention in the manipulation group while no change will occur in the placebo group.


Eligibility criteria:
healthy subjects or the reliability phase: inclusion criteria: * subjects without any history of back problems * subjects without any known pathology. exclusion criteria: * any serious spinal condition such as tumor, fracture, or infection, * signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength), * structural deformity, * spondylolithesis , * ankylosing spondylitis * spinal stenosis, * osteoporosis, * previous surgery to the back or the hip, and * current pregnancy. subjects with chronic low back pain for both the reliability and the manipulation phases: inclusion criteria: * participants should be between the age of 20 to 60 years. * have had complaints of chronic low back pain for at least three months. exclusion criteria: * any serious spinal condition such as tumor, fracture, or infection, * signs of nerve root compression (i.e. straight leg- raise ≤ 45° or diminished reflexes, sensation or lower extremity strength), * structural deformity, * spondylolithesis , * ankylosing spondylitis * spinal stenosis, * osteoporosis, * previous surgery to the back or the hip, and * current pregnancy

Keywords: chronic low back pain low back pain lumbopelvic manipulation chicago manipulation emg median frequency electromyography reliability
saline instillation before tracheal suctioning and the incidence of ventilator associated pneumonia

Conditions: Mechanical Ventilation; Critically Ill Patients

Summary: compare the incidence of ventilator associated pneumonia with or without tracheal isotonic saline instillation before tracheal suctioning


Eligibility criteria:
inclusion criteria: * consecutive patients foreseen to receive mechanical ventilation for more than 72 hours exclusion criteria: * previous mechanical ventilation in the last month * mechanical ventilation for more than 6 hours before arrival at icu, * contraindication to bronchoscopy and * be expected to die or undergo withdrawal treatment within 48 hours-

Keywords: pneumonia ventilator associated pneumonia prevention
nutritional transitions to more plant proteins and less animal proteins: understanding the induced metabolic reorientations and searching for their biomarkers (provegomics)

Conditions: Metabolic Syndrome; Hypertriglyceridemia; Fasting Blood Sugar Above Normal; Lower Than Standard HDL-cholesterol Level; Slightly Elevated Blood Pressure

Summary: the dietary shift from animal to plant protein sources is one of the key aspects of the nutritional transition towards more sustainable food system and diets. however the metabolic implication of this shift in protein sources are still poorly understood. this project aims to characterize and understand the metabolic orientations specifically induced by animal and vegetable dietary proteins, in order to better analyze the metabolic reorientations that would result from the expected increase in the share of plant proteins in different dietary contexts, especially those of the western type, often associated with the development of metabolic deregulations (obesity and cardiometabolic risk).

the main objectives of this project are: * characterize the metabolic adaptations induced by animal or plant protein diets and their repercussions in terms of physiology and health. * characterize the medium-term metabolomic signatures induced by this shift in dietary protein sources * validate, in a human population, biomarkers of dietary animal or plant proteins, previously identified in pre-clinical studies. this clinical trial is open, monocentric, controlled, randomized, with a cross experimental design. 20 men or postmenopausal women will follow for 4 weeks a controlled diet with a protein fraction constituted mainly from animal or vegetal sources. after a 2-week washout period(+21d/-7d), they will follow another 4 week of controlled diet with predominantly animal or plant protein depending on 1st intervention period diet. at the end of each intervention period, a post-prandial exploration will be conducted with the administration of a high-fat, high-sugar meal and subsequent blood and urine sampling. the order in which participants will received the two diets will be randomized.

Eligibility criteria:
inclusion criteria: * bmi between 25 and 35 kh/m² (terminals included) * waist circumference ≥ 94 cm for men and ≥80 cm for women * at the choice, one of the following criteria: triglyceridemia \> 1.49g/l, fasting blood glucose≥ 5.6 mmol/l , a hdl cholesterol \<1.03mmol/l for men or \<1.29 mmol/l for women , systolic blood pressure≥ 130 mmhg or diastolic≥ 85 mmhg . exclusion criteria: * systolic blood pressure \> 150mmhg or diastolic blood pressure \> 90mmhg * pathology and medical treatment * diabetes * smoking \> 4 cigarettes /day * alcohol consumption \> 2 glasses/day * antibiotics taken during the last 3 months before the clinical trial * specific diets

Keywords: metabolomics plant proteins, dietary meat proteins dietary proteins metabolic syndrome hypertriglyceridemia waist circumference
reduction of cesareans by nitric oxide (no) donors in post term pregnancies

Conditions: Prolonged Pregnancy; Nulliparity

Summary: the purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.

the purpose of this trial is to determine whether cervical ripening with 40 mg of isosorbide mononitrate given intravaginally at 41+0, 41+2 and 41+4 weeks reduce cesarean section in nullipara with post term pregnancies. treatments will be administered by midwifes in the maternity wards, women will be allowed to go back home in case of bishop score\<6. otherwise labor will be induced with oxytocin. if undelivered at 41+5, women with bishop score\<6 will be induced with prostaglandins according to local protocols.

Eligibility criteria:
inclusion criteria : * age \> or = 18 years old * tas \> or = 95 mmhg * singleton * nulliparity * term \> or = 41 weeks + 0 day * bishop score \< or = 5 * vertex presentation * intact membranes * no contra-indications of the study treatment * no maternal or fetal diseases which could indicate immediate labor induction * written informed consent exclusion criteria : * multiple pregnancy * multiparity * term \< 41 weeks * bishop score \> 5 * breech presentation * rupture of the membranes * previous cesarean * indication to immediate labor induction * contraindications to isosorbide mononitrate * no co-administration of antihypertensive drugs * no social security

Keywords: prolonged pregnancy nulliparity cervical ripening induced labor cesarean section
this study is being performed to evaluate the effect of genasense on the efficacy and the safety of rituximab/fludarabine combination treatment in previously untreated subjects with chronic lymphocyctic leukemia(cll)

Conditions: Lymphocytic Leukemia

Summary: to compare the efficacy and safety of combination treatment with genasense, fludarabine, and rituximab versus combination treatment with fludarabine and rituximab in previously untreated subjects with cll.


Eligibility criteria:
inclusion criteria: * previously untreated subjects with intermediate-or high-risk cll(modified rai stages i-iv) * measurable disease as primarily established by the national cancer institute-sponsored working group(nci-wg) guidelines for the diagnosis of cll * requiring therapy for active disease, as primarily defined by the nci-wg guidelines * eastern cooperative oncology group performance status \< 2 * adequate organ function determined , 14 days prior to the first dose of study medication exclusion criteria: * absolute lymphocyte count \> 100,000/ul * prior chemotherapy or other therapy for cll, including allogeneic transplant * less than 3 weeks from any prior major surgery at the time of informed consent * failure to recover from any serious adverse effect of surgery * history of autoimmune hemolytic anemia or autoimmune thrombocytopenia * active serious infection requiring systemic anti-infective therapy

Keywords: evaluate the effect of genasense on the efficacy/safety of rituximab/fludarabine treatment in untreated subjects with chronic lymphocyctic leukemia
food allergen eliminations and combined protocols for obesity reduction: a preliminary comparison study

Conditions: Obesity

Summary: screened subjects will be tested for hidden food allergies. subjects will eliminate all food that showed leukocyte reactions for 90-days. subjects will then also be invited to use the willis exercise protocol. body composition testing and body mass index calculation will be accomplished at enrollment and after completion of the 90-day study.

subjects will first be screened for cardiovascular pathologies and then tested for hidden food allergies. after the results subjects will eliminate all food that showed leukocyte reactions for 90-days. subjects will then also be invited to use the willis exercise protocol (aerobic-surge exercise \> 75% max heart rate, for 2-minutes, 5/day. body composition testing and body mass index calculation will be accomplished at enrollment and after completion of the 90-day study.

Eligibility criteria:
inclusion criteria: 1. the subject is \> 20 years of age and is willing and able to provide signed informed consent. 2. the subject has a bmi \> 30. 3. the subject is between the ages of 20 to 75 years of age. exclusion criteria: 1. cardiovascular heart disease and this includes but is not limited to history of myocardial infarction, atrial fibrillation, etc. 2. history of cerebral vascular event (stroke), traumatic brain injury, parkinson's disease or any other neural injury or disease. 3. diabetes mellitus (type i or ii) 4. pregnancy 5. participation in any other weight loss protocols, diets, or medication.

Keywords: food hypersensitivity exercise
response prediction in metastasized colorectal cancer using intratumoral thymidylate synthase

Conditions: Colorectal Cancer; Non Resectable Metastasis; Reference Lesion; Biopsy; Thymidylate Synthase Quantitation

Summary: the aim of the study was to evaluate the feasibility of ts determination in a multicenter trial setting using a central facility for measurement and confirm its role as predictive factor for 5-fu treatment in mcrc.

eligible were patients with non-resectable metastasized or recurrent histologically proven crc with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy.the biopsy was taken from the reference lesion either by surgery during primary tumor resection, by trans-cutaneous true-cut needle biopsy or by trans-anal approach. intratumoral relative ts mrna expression levels were determined using samples shipped in rna-preserving solution or as glass slides after microdissection of tumor cells. an independent company stratified the patients according to ther relative ts mrna expression level in ts low and ts high followed by randomization to receive either fufa of folfiri. response to chemotherapy was evaluated and documented according to the recist criteria after every therapy cycle.

Eligibility criteria:
inclusion criteria: * patients (\>= 18 years) with non-resectable metastasized or recurrent histologically proven crc with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy * a performance status who 0-2 (karnofsky \>= 60%) * an estimated life expectancy of at least 3 months * written informed consent exclusion criteria: * patients older than 75 years not fulfilling these criteria * brain metastases or a secondary cane * a history of a systemic palliative chemotherapy * and an adjuvant chemotherapy (within 6 months) * pregnant or nursing women * a known allergy toward irinotecanhydroclorid or of any ingredients of campto or other severe medical * laboratory and social conditions not allowing chemotherapy and follow-up

Keywords: colorectal cancer non resectable metastasis reference lesion biopsy thymidylate synthase quantitation
local infiltration analgesia for hip arthroscopy

Conditions: Pain

Summary: the purpose of this study is to examine if ultrasound guided infiltration of local anesthetic solution around the hip joint will provide effective pain control after hip arthroscopy.


Eligibility criteria:
inclusion criteria: * hip arthroscopy * ages 18-80 exclusion criteria: * history of neurological disease * diabetes * pregnancy * neuropathy * chronic narcotic use * allergy to local anesthetic solution * inability to give consent or cooperate with the study protocol

Keywords: hip arthroscopy post operative analgesia
endothelial disfunction treatment with glimepiride/metformin combination (glimetal) in type 2 diabetes patients

Conditions: Endothelial Dysfunction; Diabetes Mellitus

Summary: the purpose of this study was to evaluate the effect of the combination glimepiride/metformin over endothelial dysfunction (ed) in asymptomatic patients with type 2 diabetes mellitus (dm) using 13n-ammonia-positron emission tomography (pet).


Eligibility criteria:
inclusion criteria: * both genders * at least 18 years old * type 2 diabetes mellitus diagnosis * signed informed consent exclusion criteria: * history of smoking, hypertension, dyslipidemia, ischemic heart disease or autoimmune rheumatic diseases * pregnancy or lactation * history of abuse and/or substance dependence within 6 months preceding the survey. * history of glimepiride or metformin allergy

Keywords: endothelial dysfunction diabetes mellitus glimepiride metformin
cognitive behavioral therapy for insomnia with rtms

Conditions: Depression; Insomnia

Summary: depression and insomnia occur together in a substantial number of patients. transcranial magnetic stimulation (tms) is an effective treatment for depression, but does not help insomnia symptoms in depressed patients. a form of cognitive behavioral therapy (cbt) has been developed that specifically helps with insomnia (cbt-i). the study team will give cbt-i to patients who are being treated with tms for depression, who also have insomnia, to determine if it helps insomnia symptoms.


Eligibility criteria:
inclusion criteria: * adults aged 18-85 years old * patients starting rtms treatment for mdd * co-morbid insomnia as determined by meeting the following criteria: (a) requiring more than 30 minutes to fall asleep at the beginning of the night or more than 30 minutes of time awake after initially falling asleep for at least 3 nights per week for at least 3 months - - an insomnia severity index score of 15 or more * manifested sleep disturbances or associated daytime symptoms causing significant distress or impairment in social, occupational or other areas of functioning * reliable access to a computer with internet access. exclusion criteria: * obligation to an irregular sleep schedule that prevents the adoption of intervention strategies such as shift workers * participants who have received or are receiving cbt-i targeting insomnia in the past, or those who have initiated a new sedative medication, or sedating antidepressant within 2-weeks preceding enrollment * comorbid psychiatric disorders, including bipolar disorder, psychotic disorders or depression with psychotic features * presence of another untreated sleep disorder such as obstructive sleep apne * pregnancy * active substance use disorder within the past 3 months * use of medications that reduce the seizure threshold including buproprion, stimulants or augmenting thyroid medications (for those without history of hypothyroid)